Feasibility and Safety of Delivering a Ketone Drink to Comatose Survivors of Out-of-hospital Cardiac Arrest

NCT ID: NCT03226197

Last Updated: 2025-05-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-14
• Study Completion Date: 2019-09-13

Brief Summary

Every year, efforts are made to resuscitate about 30,000 people when their hearts stop outside of the hospital environment ('out-of-hospital cardiac arrest'). Early damage to the brain due to 'oxygen starvation' (seemingly paradoxically) gets worse when blood flow is restored. Of the 6,350 survivors admitted to intensive care units, 46% die from brain damage, and half of those who survive suffer long-term brain damage. Apart from avoiding a high temperature, nothing has been found which can protect the brain or improve outcome.

'Ketones' are chemicals naturally produced in the body from fat during starvation. They act as an energy source, but also as regulators of metabolism, and appear to protect cells from damage when oxygen supplies are scarce, or when blood flow is restored. The investigators want to see whether a ketone drink will protect the brain after out-of-hospital cardiac arrest.

The investigators will study 10 cardiac arrest patients, and participants will be given the ketone drink via a feeding tube (which is routinely passed into the stomach in such cases). The investigators shall check that the drink is absorbed, and measure the ketone levels in the blood. The investigators will also measure important aspects of blood chemistry (including pH and blood sugar) and collect data on brain (electrical recordings called 'EEG' and 'SSEP') and heart function (ultrasound scans or 'echocardiographs') - both of which it is hoped might improve - in order to demonstrate that this is possible if it is to be included in a subsequent large trial. The study will be scrutinised by world experts in the field, who have also helped design the study.

If this pilot study is a success, the investigators will apply to a major grant body to fund an appropriately-powered randomised controlled trial to determine whether ketones improve neurological outcome and survival in these patients. Results will also allow similar studies to be planned in heart attack, stroke and traumatic brain injury.

Conditions

Out-Of-Hospital Cardiac Arrest

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Study group

Ketone ester drink to be administered by nasogastric tube. Initial bolus dose of 25 ml on enrollment. After 1 hour, begin 47 hr infusion at 6 ml per hour.

Group Type: EXPERIMENTAL

Ketone ester drink

Intervention Type: DIETARY_SUPPLEMENT

Ketone ester drink

Interventions

Ketone ester drink

Ketone ester drink

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Aged 18 years or above
• Male or female
• Comatose survivors of out-of-hospital cardiac arrest, defined as return of spontaneous circulation for at least 5 minutes with a score of <8 on the Glasgow Coma Scale
• For admission to intensive care unit for full, active treatment

Exclusion Criteria

• Primary neurological or intracranial cause of cardiac arrest
• In-hospital cardiac arrest
• Inclusion in another trial at time of recruitment
• Over 4 hours from time of return of spontaneous circulation to enrollment

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University College, London

OTHER

Sponsor Role: collaborator

Barts & The London NHS Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ajay Jain, MBBS MD

Role: PRINCIPAL_INVESTIGATOR

Consultant Cardiologist

Locations

Barts Heart Centre

London, , United Kingdom

Countries

United Kingdom

Other Identifiers

011774

Identifier Type: -

Identifier Source: org_study_id